Legislating Medicine

When anecdotes trump data, health policy can become engulfed by bad science. Alena Allen eloquently captures the pitfalls of this phenomenon in her article, Dense Women, which provides a comprehensive normative and descriptive analysis of breast density notification statutes. To my knowledge, Allen is the first legal scholar to tackle this important issue. While breast density notification statutes vary by state, they each share a common goal: ensuring that physicians provide certain information to women who have dense breast tissue and directing women (to varying degrees) to speak to their doctors about further medical tests.

Breast density notification statutes were passed in response to heart-breaking stories of women who were diagnosed with breast cancer despite initially receiving negative mammogram results. One of the leading advocates is Nancy Cappello, who was diagnosed with breast cancer despite ten years of negative mammograms, and was eventually told that only an ultrasound could detect her cancer, given her dense tissue. Following a mastectomy, chemotherapy, radiation, and hormone treatment, Cappello began advocating for legislation mandating that physicians inform women when they have dense breasts. As Allen writes: “Their message is hard to resist. They are advocating to inform and empower women. They want to standardize, improve, and promote increased doctor-patient communication. Their message is so enticing that state legislatures across the country are listening.” In 2009, Connecticut (Cappello’s home state) became the first state to pass such a law, and twenty-three states have followed. (Legislation is pending in ten states, and a bill was recently introduced in the U.S. House of Representatives.).

While acknowledging that the stories of Cappello and others are “compelling,” Allen quite firmly (and convincingly) argues that personal “narratives always militate in favor of action, without fully appreciating the downside consequences.” The data are startling; according to one recent study, for every 10,000 women with dense breasts, additional testing will result in breast cancer being prevented in four women, though 3,500 unnecessary biopsies would be performed. This represents a high false-positive rate; 99.96% of women with dense breast tissue will have undergone additional screening tests but have no cancer, and 35% of these women would have undergone a biopsy just to be sure. Biopsies are not without risks, and all the additional testing comes with financial costs and anxiety for women who are undergoing the procedures. As a recent article in the New England Journal of Medicine reports, dense breast tissue is normal and common, present in 40-50% of women. Moreover, given changes in radiological reporting systems, tissue that is deemed dense in one year may not be deemed dense in another, and there is “little evidence to support widespread supplemental screening.” In short, as Allen explains, notification laws strongly nudge physicians to order new tests not for reasons of medical necessity, but out of fear of lawsuits should their patient not be in that 99.96%.

Lurking beneath the push for breast density notification statutes is a controversial premise—that the practice of medicine can be enhanced when elected officials dictate the standard of care. As Allen illustrates, these broader questions command attention. For example, when data do not corroborate anecdotal evidence, should lawmakers tell physicians what they should, and should not, say to patients? And, should insurance companies have to foot the bill for medical treatment that is encouraged by a state but not supported by medical science?

As Allen writes, “most notification laws undermine women rather than empower them”—this is accomplished by “nudging, prodding, or pushing women to act.” Some states push women towards additional testing without requiring that insurance companies cover the costs. In fact, only two states (Connecticut and New Jersey) require that insurance companies cover the costs of additional screenings encouraged by the notification laws.

Other important contributions of Dense Women include Allen’s state-by-state analysis of breast density notification statutes. Here, Allen goes beyond merely classifying the various statutes into distinct categories; she analyzes which statutes are more likely to cause harm to women. Allen not only provides a compelling argument that questions the public health benefits of breast density notification statutes, she correctly links this debate to larger questions in health law and health policy. These include: how best to incorporate evidence-based medicine and comparative effectiveness research into health care delivery and best practices; paternalism in health care (particularly for women’s health issues); 1st Amendment issues and compelled speech on the part of the provider; and the role of medical malpractice (including doctrines such as loss of chance and negligence per se) in incentivizing sound medical care.

It’s often said that, in the realm of medicine, information is power. What Dense Women demonstrates is that this maxim ought to be qualified. This is particularly true when the evidence-based foundations of medicine are not applied to health policy. Allen’s analyses and conclusions are important, and lawmakers and health policy experts stand to gain from her thorough examination of the topic. Allen’s call for caution must be taken seriously.

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